Multidrug Resistant Gram-negative Pathogen Infections in High Risk Neonates in the Northeast of Mexico

NCT04812847 | Completed

• 1 other identifier: InfGNMDR-Neo
• Study Type: observational
• Target: 597
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this project is to establish a prospective cohort to measure the Gram-negative infection burden in neonates under special care in a regional referral hospital, and to characterize all microorganisms isolates from these subjects at the phenotype and genotype level, specifically in relation to the expression of multi-drug resistance (MDR) associated genes (Molecular characterization of Gram-negative MDR isolates).

Conditions

Infant Newborn Disease

Keywords

Drug Resistance, Multiple, Bacterial.

Outcome Measures

Primary Outcomes (1)

• Burden of Gram Negative organisms infections

  The isolation of a gram-negative organism, from any clinical site, in neonates under clinical care in special care nursery; Incidence = New cases during the study period, Prevalence = Total cases during the study period.

  Through study completion, an average of three months

Secondary Outcomes (2)

• Odds ratio for the occurrence of Gram-negative MDR infections

  Through study completion, an average of three months

• Risk factors for the occurrence of Gram-negative MDR infections.

  Through study completion, an average of three months

Study Arms (2)

Gram negative infection, MDR present

Neonates with one or more gram-negative bacterial isolates with MDR characteristics during their clinical course in the Neonatal Intensive Care Unit of the study hospital.

Diagnostic Test: Identification of MDR characteristics

Gram negative infection, MDR absent

Neonates with one or more gram-negative bacterial isolates with no MDR characteristics during their clinical course in the Neonatal Intensive Care Unit of the study hospital.

Diagnostic Test: Identification of MDR characteristics

Interventions

Identification of MDR characteristics DIAGNOSTIC_TEST

Identification of MDR in culture media, followed by amplification of related genes from the bacterial isolates

Gram negative infection, MDR absent; Gram negative infection, MDR present

Eligibility Criteria

• Age: 1 Day - 180 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Neonates, both at term and preterm, of any gestational age, under special care in the Neonatology Division of a tertiary care regional perinatal center in the Northeast of Mexico.

You may qualify if:

• Neonates of either sex, and any gestational age, admitted to the special care nursery of Hospital Regional Materno Infantil (Includes also out-born and transferred babies),
• Treating physician´s order to draw any biological sample and send it for culture at the hospital´s clinical laboratory.
• A culture with an isolate of Gram-negative bacteria.

You may not qualify if:

• Any culture negative for bacterial growth
• Any culture with Gram-positive bacteria, or fungus growth.

Sponsors & Collaborators

• Instituto Tecnologico y de Estudios Superiores de Monterey: lead

Study Sites (1)

Hospital Regional Materno Infantil de Alta Especialidad, Secretaría de Salud

Guadalupe, Nuevo León, 67140, Mexico

Location

Biospecimen

Retention: SAMPLES WITH DNA

Isolated microorganism, recovered from culture plates, cryo-preserved at -80°C media until analysis, and thawed and seeded onto EMB (Eosin-Methylene Blue) agar plates, will be used for qrtPCR (quantitative real-time Polimerase Chain reaction)amplification of fragments of genes of interest.

Study Officials

• Victor Javier Lara-Diaz, MD, PhD

  Tecnológico de Monterrey, Escuela de Medicina y Ciencias de la Salud

  STUDY CHAIR

• Cuauhtémoc Licona-Cassani, PhD

  Tecnológico de Monterrey, Centro de Biotecnología FEMSA

  PRINCIPAL INVESTIGATOR

• Marion Genevieve Brunck, PhD

  Tecnológico de Monterrey, Escuela de Ingeniería y Ciencias, GIEE on Translational Omics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor-Researcher

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 24, 2021
• Study Start: June 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 1, 2023

Record last verified: 2023-02

Locations

ME (1)